NCT07077772

Natriuresis-guided Depletion After Cardiac Surgery

Evaluation of Natriuresis-guided Depletion After Cardiac Surgery: a Monocentric, Open-label, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fluid overload (FO) is a common complication after cardiac surgery, associated with increased morbidity and mortality. Loop diuretics, especially furosemide, are routinely used to manage FO, but their use is often empirical. Recent data suggest that natriuresis-guided furosemide titration using point-of-care urinary sodium sensors (LAQUAtwin NA-11, Horiba) may improve the efficiency and safety of fluid removal, but no randomized trial has yet evaluated this approach in postoperative cardiac surgery patients Our goal is to assess the clinical impact, safety, and feasibility of a natriuresis-guided furosemide protocol after cardiac surgery requiring cardiopulmonary bypass.

Conditions

• Cardiac Surgery
• Diuresis
• Congestion, Venous
• Sodium Depletion
• Fluid Over-load

Interventions

Type	Name	Description
DRUG	Furosemide intravenous titration based on natriuresis	Furosemide IV, 20 mg starting dose, titrated every 6 hours based on urinary sodium measured by the LAQUAtwin NA-11 device. Urine output will be measured and recorded every 4 hours to ensure accurate diuresis tracking. If natriuresis is \< 70 mmol/L, the furosemide dose will be doubled, with a maximum limit of 200 mg per bolus. If natriuresis is ≥ 70 mmol/L, the current dose will be maintained. Blood electrolyte panels and renal function assessments will be performed twice daily throughout the protocol. In the event of hemodynamic instability, a complete echocardiographic assessment will be performed for all patients to detect potential surgical complications, along with a hemodynamic evaluation to guide appropriate management.
DRUG	Furosemide intravenous titration based on clinical examination	Furosemide IV, 20 mg starting dose, titrated every 6 hours clinical evaluation. Urine output will be measured and recorded every 4 hours to ensure accurate diuresis tracking. The furosemide dosage will be adjusted based on urine output with a maximum bolus dose of 200 mg. Dose adjustments will be reassessed every 6 hours throughout the study period. Blood electrolyte panels and renal function assessments will be performed twice daily throughout the protocol. In the event of hemodynamic instability, a complete echocardiographic assessment will be performed for all patients to detect potential surgical complications, along with a hemodynamic evaluation to guide appropriate management.

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-07-22
• Last updated: 2026-01-21

Locations

1 site across 1 country: France